← FDA ENFORCEMENT
Z-1449-2026Class II
Olympus Corporation of the Americas
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-03-04
Distribution
US Nationwide Distribution.
Firm state
PA
Product quantity
91 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Product description
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Code / lot info
Model No. A4741; UDI: 04042761006514; All Lots.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →